CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWTother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04484948
NCT04484948N/ACompleted

Utility of Breath-holding Test for Assessment of Pulmonary Disease Severity in Patients With Systemic Sclerosis

Seoul National University Hospital·interventional·Posted Jul 24, 2020·Updated Jun 2, 2023

In Brief

A clinical study evaluating scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWT for Systemic Sclerosis. Completed, enrolled 120 participants across 1 site.

Detailed Summary

This study aims to evaluate the utility of breath-holding test as a marker of pulmonary disease severity in patients with systemic sclerosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 24, 2020
Enrollment StartAug 12, 2020
Primary CompletionJan 29, 2021
Study CompletionMay 31, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.9 years ago

Interventions

scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWTother

1. Participants will perform the SHAQ. 2. BHT and 6MWT will be performed in the randomized way for each participant. 3. For BHT, the participants will be told to sit comfortably on a chair, and breath normally. After 1 minute, they were required to make a maximum expiration followed by a maximum inspiration and to hold the breath as long as possible at maximum inspiratory level. This procedure was repeated three times, with 5-minute intervals between the tests. 4. 6MWT will be performed according to the ATS guidelines. 5. Information on CXR, TTE, and PFT (FVC%, DLCO%) will be obtained from the medical record if the data was obtained within 3 months. If not, the tests will be performed. 6. BHT and PFT will be followed by six months after the first breath-holding test to confirm the responsiveness. 7. Additional 30 patients with systemic sclerosis will be collected to perform the test-retest reliability of BHT.